Multiple Disability, Osteoporosis
Conditions
Brief summary
The main purpose of this study is the evaluation of the efficacy of zoledronic acid on bone density in children with osteoporosis caused by multiple disabilities. Secondary purposes are: 1. Description of child population with osteoporosis in the context of motor impairment in Lorraine region 2. Description of osteoporosis stage (level of bone mineralization and clinical consequences) in children with multiple disabilities 3. Description of current osteoporosis preventive care 4. Description of risk factors associated to bone status (drugs) 5. Evaluation of zoledronic acid treatment on fracture numbers 6. Evaluation of zoledronic acid on phosphocalcic profile 7. Description of side effects of zoledronic acid in this indication 8. Description of treatment effects in the sub-population of children with Rett syndrome.
Interventions
DRUGZoledronic Acid
Treatment of osteoporosis
Sponsors
Central Hospital, Nancy, France
Study design
Observational model
CASE_CROSSOVER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Non refusal of parents of participation of their child to the study * Patients followed for multiple disabilities * Osteoporosis: lumbar osteodensitometry z-score \<-2.5 SD associated or not to pathologic fracture
Exclusion criteria
* Bone pathology due to other genetic reasons (rickets, osteogenesis imperfecta) * Absence of multiple disabilities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline (before start of zoledronic acid treatment) lumbar bone density | through study completion, 4 years | reported in Z-score |
Secondary
| Measure | Time frame |
|---|---|
| Sex | Baseline |
| Height | Baseline |
| Weight | Baseline |
| Occurrence of bone fractures | Until baseline |
| Long-term administration of vitamin/calcium supplement or not | baseline |
| Age | Baseline |
| Number of fractures after the start of zoledronic acid treatment | through study completion, 4 years |
| Change from baseline phosphocalcic profile evaluation | through study completion, 4 years |
| Frequency of side effects | through study completion, 4 years |
| Change from baseline lumbar bone density in sub-population of children with Rett syndrome after 1 year of zoledronic acid treatment | 1 year from baseline |
| Administration of drugs or not | baseline |
Countries
France
Outcome results
None listed